EP3288460B1 - Blasenereigniserkennung zur diagnose von harninkontinenz oder behandlung von erkrankungen der unteren harnwege - Google Patents

Blasenereigniserkennung zur diagnose von harninkontinenz oder behandlung von erkrankungen der unteren harnwege Download PDF

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EP3288460B1
EP3288460B1 EP16724991.1A EP16724991A EP3288460B1 EP 3288460 B1 EP3288460 B1 EP 3288460B1 EP 16724991 A EP16724991 A EP 16724991A EP 3288460 B1 EP3288460 B1 EP 3288460B1
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Prior art keywords
bladder
patient
signal
event
pressure
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English (en)
French (fr)
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EP3288460A1 (de
Inventor
Margot S. DAMASER
Swarup Bhunia
Robert KARAM
Steve Majerus
Dennis BOURBEAU
Hui Zhu
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Cleveland Clinic Foundation
Case Western Reserve University
US Department of Veterans Affairs VA
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Cleveland Clinic Foundation
Case Western Reserve University
US Department of Veterans Affairs VA
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Priority to EP19164995.3A priority Critical patent/EP3524154B1/de
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/20—Measuring for diagnostic purposes; Identification of persons for measuring urological functions restricted to the evaluation of the urinary system
    • A61B5/202—Assessing bladder functions, e.g. incontinence assessment
    • A61B5/205—Determining bladder or urethral pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/07—Endoradiosondes
    • A61B5/076—Permanent implantations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/20—Measuring for diagnostic purposes; Identification of persons for measuring urological functions restricted to the evaluation of the urinary system
    • A61B5/202—Assessing bladder functions, e.g. incontinence assessment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
    • A61B5/6874—Bladder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7203—Signal processing specially adapted for physiological signals or for diagnostic purposes for noise prevention, reduction or removal
    • A61B5/7207—Signal processing specially adapted for physiological signals or for diagnostic purposes for noise prevention, reduction or removal of noise induced by motion artifacts
    • A61B5/721—Signal processing specially adapted for physiological signals or for diagnostic purposes for noise prevention, reduction or removal of noise induced by motion artifacts using a separate sensor to detect motion or using motion information derived from signals other than the physiological signal to be measured
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7235—Details of waveform analysis
    • A61B5/7253—Details of waveform analysis characterised by using transforms
    • A61B5/726—Details of waveform analysis characterised by using transforms using Wavelet transforms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7271—Specific aspects of physiological measurement analysis
    • A61B5/7282—Event detection, e.g. detecting unique waveforms indicative of a medical condition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36007—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of urogenital or gastrointestinal organs, e.g. for incontinence control
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128—Control systems
    • A61N1/36135—Control systems using physiological parameters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128—Control systems
    • A61N1/36146—Control systems specified by the stimulation parameters
    • A61N1/36167—Timing, e.g. stimulation onset
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    • A61B2560/02—Operational features
    • A61B2560/0204—Operational features of power management
    • A61B2560/0214—Operational features of power management of power generation or supply
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B2560/02—Operational features
    • A61B2560/0204—Operational features of power management
    • A61B2560/0214—Operational features of power management of power generation or supply
    • A61B2560/0219—Operational features of power management of power generation or supply of externally powered implanted units
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0247—Pressure sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0031—Implanted circuitry
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/03—Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs

Definitions

  • the present disclosure relates generally to the diagnosis of urinary incontinence and the treatment of lower urinary tract dysfunction and, more specifically, to systems and methods that can categorize detected bladder events, which can be used for the diagnosis of urinary incontinence or the treatment of lower urinary tract dysfunction.
  • Urinary incontinence is a condition affecting 200 million people worldwide that significantly reduces quality of life. Diagnosis of urinary incontinence can range from a simple clinical evaluation based on history and a physical exam to more complex tests, such as a clinical urodynamics examination, to determine if the patient has stress urinary incontinence or urgency urinary incontinence due to overactive bladder or neurogenic detrusor overactivity. Diagnosis of lower urinary tract dysfunction with urodynamics has historically relied on data acquired from two or more sensors using nonphysioiogically fast cystometric filling. Extended ambulatory urodynamics testing can provide more data collected at physiologically normal fill rates. However, this two-sensor system provides an inconvenient and uncomfortable solution for extended ambulatory urodynamics testing. An alternative method of measuring bladder activity over extended durations at natural fill rates would improve diagnosis of urinary incontinence.
  • US2007/255176 describes an implantable stimulation system that learns to identify a voiding signature of a bladder and log the voiding events.
  • the system may adjust stimulation therapy according to the voiding signature.
  • the system includes an implantable neurostimulator and a sensor that senses a physiological event indicative of a voiding event.
  • the sensor may sense neurological activity, bladder dimensions, bladder characterizes, external wetness, or other activities related to patient voiding.
  • the neurostimulation correlates the sensed event to an input by a user to learn what sensed data is indicative of a voiding event.
  • the present disclosure relates generally to the diagnosis of urinary incontinence or the treatment of lower urinary tract dysfunction and, more specifically, to systems and methods that can categorize detected bladder events, which can be used for the diagnosis of urinary incontinence or the treatment of lower urinary tract dysfunction.
  • the systems and methods can categorize bladder events detected by a single sensor (e.g., a bladder pressure sensor) in real time.
  • the bladder events can be categorized into three types: bladder contraction resulting in voluntary voiding, bladder contraction without voluntary voiding, and a non-contraction event that would change bladder pressure, such as a cough.
  • the diagnosis and treatment can be facilitated based on the automated categorization of the bladder events.
  • the present disclosure includes a system that can categorize detected bladder events.
  • the system comprises: a sensing device adapted to be located within a patient's bladder, comprising: a pressure sensor comprising a bridge-type circuit adapted to directly detect a pressure within the patient's bladder; a wireless transceiver adapted to transmit a signal indicating the pressure within the patient's bladder; and a battery adapted to provide power to the pressure sensor; and a signal processing device comprising: a wireless transceiver adapted to receive the signal indicating the detected pressure within the patient's bladder; and a processor to execute instructions stored in memory to process the signal and at least: filter the signal indicating the detected pressure with a low-pass filter with a cutoff frequency tuned for the patient's bladder to provide a filtered signal; apply a multi-level discrete wavelet transform to the filtered signal to provide a transformed signal in a wavelet domain; apply an adaptive thresholding procedure to the transformed signal in the wavelet domain to detect a bladder event of the patient; and character
  • the present disclosure includes a method for categorizing detected bladder events.
  • the method can be performed by a signal processing device comprising a processor.
  • the method comprises: receiving, by a signal processing device comprising a processor, a signal indicating a pressure detected within a patient's bladder from a sensing device, wherein the sensing device is located within the patient's bladder and comprises; a pressure sensor comprising a bridge-type circuit adapted to directly detect the pressure within the patient's bladder; a wireless transceiver adapted to transmit the signal indicating the pressure within the patient's bladder; and a battery adapted to provide power to the pressure sensor; and processing, by the signal processing device, the signal indicating the pressure comprising: applying, by the signal processing device, a low pass filter to the signal with a cutoff frequency to remove noise from the signal, wherein the cutoff frequency is tunable; applying, by the signal processing device, a multi-level discrete wavelet transform to the filtered signal to provide a transformed signal in a wavelet domain; and applying
  • the term "sensing device” can refer to a device that can detect a property of a subject's bladder. In some instances, at least a portion of the sensing device can be implanted within a wall of the subject's bladder to detect the property of the subject's bladder.
  • the sensing device can include a sensor specific to the property that is detected.
  • the sensing device includes an implantable pressure sensor, comprising a bridge-type circuit, to detect a pressure within the bladder.
  • the sensing device also includes additional components, such as a transmitter, a battery, as defined in the independent claims.
  • the sensing device including the pressure sensor can be implanted within a wall of the patient's bladder.
  • the sensing device can include an implantable pressure sensor and another external sensor (e.g., an accelerometer, such as a three-axis accelerometer). While the pressure sensor can be implanted within the wall of the bladder, the external sensor can be located external to the subject's body.
  • an accelerometer such as a three-axis accelerometer
  • the term "signal processing device” refers to a device that includes at least a processor to perform signal processing on a signal including the detected pressure and detect a bladder event based on the processed signal.
  • the signal processing device can be a real-time computing platform, such as an application specific integrated circuit (ASIC), an embedded circuit running software, custom programmable hardware, or software on a conventional computing platform, such as a personal computer, a tablet computer, a smartphone, or the like.
  • ASIC application specific integrated circuit
  • the signal processing device can be implantable.
  • the signal processing device can be external.
  • the signal processing device can be at least partially implanted and at least partially external.
  • the term "bladder event" can refer to a detectable change in the bladder pressure.
  • the detected bladder event can be characterized as a contraction event or a non-contraction event.
  • the contraction event can be further classified as a voiding contraction event (e.g., due to a neural signal) or a non-voiding contraction event (e.g., due to a non-neural event, like coughing, laughing, change in posture, or the like).
  • the non-contraction event can include an artifact.
  • voiding contraction can refer to a contraction of the detrusor muscle of the bladder, which generates an urge to urinate. In some instances, if not stopped, the bladder contraction can force urine out of the bladder and/or cause pain.
  • the term "signal processing” can refer to one or more techniques that can improve the accuracy and reliability of an input signal (e.g., the signal from the pressure sensor).
  • the signal processing can include one or more techniques often applied to biomedical signals to condition the signal, including digital filtering, multi-level wavelet approximations, and the like.
  • the term "thresholding procedure” can refer to a multi-resolution, context-aware wavelet analysis procedure that efficiently considers local and global trends in the signal.
  • the thresholding procedure can include a set of tunable parameters.
  • the thresholding procedure can include pattern matching.
  • the term "tunable parameter" can refer to an adjustable variable that has a documented effect on behavior that can be adjusted for a specific patient.
  • the tunable parameter can be part of a set of tunable parameters.
  • the term “neuromodulation device” can refer to a device that can stimulate one or more nerves to control over-active bladder and/or incontinence.
  • the stimulation can be an electrical stimulation.
  • the stimulation can be "conditional" so that the stimulation occurs based upon detection of a bladder contraction.
  • the term "subject” can refer to any warm-blooded organism including, but not limited to, a human being, a pig, a rat, a mouse, a dog, a cat, a goat, a sheep, a horse, a monkey, an ape, a rabbit, a cow, etc.
  • the terms “patient” and “subject” can be used interchangeably herein.
  • the present disclosure relates generally to the diagnosis of urinary incontinence and the treatment of lower urinary tract dysfunction and, more specifically, to systems and methods that can categorize detected bladder events, which can be used for the diagnosis of urinary incontinence or the treatment of lower urinary tract dysfunction.
  • the detected bladder events can be classified into different categories, including contraction event and non-contraction event.
  • the systems and methods described herein require only a single sensor (e.g ., a pressure sensor implanted into the bladder wall) to record the signal that is used to detect and categorize the bladder events. This single sensor is less invasive than traditional solutions that generally rely on two pressure sensors and/or two catheters to record bladder events, making the previous solutions uncomfortable, impractical, and, often, non-physiological.
  • the systems and methods described herein can accomplish the categorization of the bladder events with a high degree of accuracy and a low false positive rate.
  • the systems and methods described herein utilize signal processing techniques often applied to biomedical signals to detect and categorize the bladder events from the signal recorded by the single sensor. For example, digital filtering and multi-level wavelet approximations can be used to condition the input before applying a multi-resolution context-aware thresholding technique that efficiently considers local and global trends in the signal to facilitate categorizing the bladder events.
  • the context-aware thresholding technique can utilize one or more tunable parameters that can be tuned to the individual subject to achieve an optimal result for the individual subject.
  • One aspect of the present disclosure can include a system 10 ( FIG. 1 ) that can categorize detected bladder events, which can be used for the diagnosis of urinary incontinence or the treatment of lower urinary tract dysfunction.
  • the system 10 can include a single sensing device 12 that can detect a property of the bladder (e.g., a pressure within the bladder) and transmit a signal that includes the detected property and a signal processing device 14, which can detect and categorize the detected bladder events from the signal.
  • the bladder events can be categorized as a contraction event (which can be further classified as a voiding event or a non-voiding event) or a non-contraction event.
  • the system 10 does not require a second sensing device and can categorize the detected bladder events from a single sensing device 12.
  • the sensing device 12 can be an in vivo sensor that can be implanted within body tissue or a fluid-filled cavity.
  • the sensing device 12 can be implantable within a subject's bladder.
  • the sensing device 12 can be implantable within a wall of the bladder where lumen pressure is transduced.
  • the sensing device 12 can be made of a biocompatible material, coated with a biocompatible material, and/or housed within a biocompatible material.
  • the sensing device 12 can be delivered, in some instances, into the bladder by a cytoscope.
  • the sensing device 12 can be at least partially hermetically sealed and sized and dimensioned to facilitate the delivery by a 24-French cytoscope (e.g ., measuring no larger than 3.5 x 7 x 15 mm).
  • the sensing device 12 can also be sized and dimensioned to erosion and migration through the bladder muscle.
  • the sensing device 12 can include at least a pressure sensor 16, a wireless transceiver 18, and a rechargeable battery 20.
  • the pressure sensor 16 can include at least a bridge-type configuration to detect changes in the pressure of the bladder.
  • the pressure sensor 16 can be implemented by electrical resistors, piezoresistive components, resistors implemented on a MEMS device, or the like.
  • the pressure sensor 16 can be included in a circuit with components accounting for offset or drift cancellation.
  • the wireless transceiver 18 can send a signal including the detected pressure to the signal processing device 14.
  • the rechargeable battery 20 can provide power to the pressure sensor 16, the wireless transceiver 18, and/or additional components of the sensing device 12. In some instances, the rechargeable battery 20 can provide power without being recharged for at least 12 hours.
  • the rechargeable battery 20 can provide power without being recharged for at least 24 hours. In still other instances, the rechargeable battery 20 can provide power without being recharged for at least 48 hours.
  • the rechargeable battery 20 can be recharged based on a received radio frequency (RF) signal.
  • the wireless transceiver 18 can receive the RF signal and facilitate recharging the rechargeable battery 20.
  • the sensing device 12 can send a signal reflective of the detected pressure to the signal processing device 14.
  • the signal processing device 14 can include a transceiver 22 (that includes at least a receiver) to receive the transmitted signal.
  • the signal processing device 14 also includes a processor 24 that can process the transmitted signal to accomplish the characterization of the bladder events.
  • a signal processing unit (SP) 26 of the signal processing device 14 can utilize signal processing techniques often applied to biomedical signals to condition the signal from the sensing device 12.
  • the signal processing techniques can remove noise (e.g ., background electrical noise, biological noise, and the like) from the biological signal.
  • the signal processing techniques can include digital filtering, multi-level wavelet approximations, etc.
  • the signals are conditioned by the signal processing techniques before a characterization unit (DC) 28 of the signal processing device 14 applies a multi-resolution context-aware thresholding technique to the signal.
  • the multi-resolution context-aware thresholding technique can be used to characterize a detected bladder event as a contraction event (which can be further characterized as a voiding contraction or a non-voiding contraction) or a non-contraction event.
  • the multi-resolution context-aware thresholding technique can efficiently consider local and/or global trends in the signal prior to making a decision whether or not to stimulate.
  • the multi-resolution context-aware thresholding technique can be customized for an individual patient.
  • the multi-resolution context-aware thresholding technique can depend on one or more tunable parameters that can be tuned for the individual patient, achieving the highest level of accuracy possible for the patient.
  • the tunable parameters can each exhibit a documented effect on behavior of the signal processing device 14 with regard to when it recommends stimulating the bladder.
  • the tunable parameters can be adjusted and stored in the memory of the signal processing device 14.
  • the tunable parameters can be adjusted and sent via a wireless signal to the signal processing device 14. Examples of the tunable parameters can include a window size, a sensitivity, or the like.
  • a system 30 can include an external sensing device 32 to aid in the event detection by the signal processing device 14.
  • the external sensing device 32 can be located on or near the abdomen of the subject.
  • the external sensing device 32 in some instances, can include a three-axis accelerometer to detect external motion (e.g ., of the abdomen).
  • the signal from the sensing device 12 can be correlated to a signal from the external sensing device 32 by the signal processing device 14.
  • the signal processing device 14 can characterize a detected bladder event as a contraction event or a non-contraction event.
  • the signal from the external sensing device 32 can indicate movement of the abdomen during a non-contraction event, but no movement of the abdomen during a contraction event.
  • the signal processing device 14 can reject the non-contraction event from further processing.
  • FIG. 3 shows a conditional stimulation system 34, which is an example application that can use the categorized bladder events.
  • the conditional stimulation system 34 includes a single sensing device 12 (e.g ., a pressure sensor located within a subject's bladder) and a signal processing device 14.
  • the signal processing device 14 can signal a neuromodulation device 36 (e.g ., including an electrical stimulator, a magnetic stimulator, or the like) to deliver a stimulation.
  • the stimulation can be used to prevent voiding and/or to prevent leakage depending on the event characterization.
  • the signal processing device 14 can also configure one or more parameters of the stimulation based on the detected pressure so that the stimulation is patient-specific.
  • the signal processing device 14 can send a signal to the stimulator of the neuromodulation device 36 indicating a need for stimulation (e.g. , based on one or more results of the multi-resolution context-aware thresholding procedure).
  • the signal in some examples, can also include one or more parameters for the stimulation.
  • the signal sent from the signal processing device 14 to the stimulator of the neuromodulation device 36 can be a digital signal.
  • the digital signal can be transmitted wirelessly, sent through a wireless transmitter of the signal processing device 14 to a wireless receiver of the stimulator of the neuromodulation device 36.
  • the stimulator of the neuromodulation device 36 can provide an electrical signal for bladder stimulation based on a signal from the signal processing device 14 indicating that a condition has occurred in the bladder that necessitates the stimulation.
  • Another aspect of the present disclosure can include methods that can be used for characterizing bladder events.
  • One example of a method 40 for categorizing detected bladder events for the diagnosis of urinary incontinence or the treatment of lower urinary tract dysfunction is shown in FIG. 4 .
  • Another example of a method 50 for individualized conditional bladder stimulation is shown in FIG. 5 .
  • the methods 40 and 50 are illustrated as process flow diagrams with flowchart illustrations, which can be implemented by an ASIC and/or by a general purpose computer processor. For purposes of simplicity, the methods 40 and 50 are shown and described as being executed serially; however, it is to be understood and appreciated that the present disclosure is not limited by the illustrated order as some steps could occur in different orders and/or concurrently with other steps shown and described herein. Moreover, not all illustrated aspects may be required to implement the methods 40 and 50.
  • FIG. 4 illustrates a method 40 for categorizing detected bladder events.
  • the categorized bladder events can be utilized for the diagnosis of urinary incontinence or the treatment of lower urinary tract dysfunction.
  • the method 40 can be performed, for example, by the system 10 shown in FIG. 1 .
  • a signal can be received (e.g ., by a signal processing device 14) indicating a pressure detected within a bladder (e.g ., from a sensing device 12 including a pressure sensor 16).
  • a sensing device 12 including a pressure sensor 16 e.g ., the sensing device can be implanted within a wall of the bladder.
  • the pressure sensor can detect changes in the pressure corresponding to various bladder events (e.g ., contraction events or non-contraction events). These changes can be included in the signal.
  • the signal can be wirelessly transmitted from the sensing device and received by the signal processing device.
  • the signal processing device can perform one or more pre-processing techniques on the signal before bladder events are detected.
  • the pre-processing techniques can include those techniques that are often applied to biomedical signals to condition the biomedical signals for further processing.
  • One example pre-processing technique can include filtering the signal ( e.g., via a digital low pass filter).
  • the low pass filtering can include a exponential moving average with a certain low pass cutoff frequency.
  • a bladder event can be detected ( e.g ., by a signal processing device 14) based on the detected pressure within the signal.
  • the signal can undergo a multi-level discrete wavelet decomposition procedure.
  • the multi-level wavelet decomposition can extract frequencies of interest corresponding to the bladder event.
  • the wavelets can be constructed to minimize the number of filter coefficients required to approximate a given signal, reducing the computational burden of the method 40.
  • the bladder event can be characterized (e.g ., by a signal processing device 14) as a contraction event or a non-contraction event.
  • the characterization can be based on an adaptive thresholding and classification procedure.
  • the adaptive thresholding can include a multi-resolution context-aware thresholding technique that efficiently considers local and global trends in the signal to facilitate the classification.
  • the thresholding procedure can be customized for an individual patient, depending on one or more tunable parameters to achieve the highest level of accuracy possible for the patient.
  • the tunable parameters can be adjusted and sent via a wireless signal to the signal processing device.
  • the output of the method 40 can include the classified events (e.g., either contraction events - which can be further classified as voiding contractions or non-voiding contractions - or non-contraction events).
  • the output can be used in the diagnosis of urinary incontinence or the treatment of lower urinary tract dysfunction.
  • the treatment of lower urinary tract dysfunction can include conditional bladder stimulation to block voiding or to prevent leakage when the bladder event is characterized as the contraction event,
  • one or more parameters of the stimulation can be configured based on the detected pressure.
  • FIG. 5 shows a method 50 for individualized conditional bladder stimulation.
  • the method 50 can be executed, for example, by the system 34 of FIG. 3 .
  • one or more tunable parameters of a thresholding procedure can be adjusted based on one or more characteristics of the patient. Adjusting the tunable parameters for the patient creates a bladder stimulation mechanism that is geared to the patient rather than geared for a population of patients. Accordingly, the thresholding procedure can be adapted to different patients through the configuration of multiple tuning parameters.
  • a signal from a sensing device within the patient's bladder can be received.
  • the sensing device can include a pressure sensor.
  • the sensing device can also include a three-axis accelerometer, which can be used to reject pressure signals associated with one or more artifacts (e.g ., a motion artifact). This can facilitate the detection of bladder contractions without the need for an abdominal pressure sensor.
  • it can be determined whether the bladder has contracted. This determination can be used to decide whether to stimulate the bladder.
  • a stimulator can be alerted to stimulate the bladder when the bladder has contracted. For example, the alert can be a digital signal triggered by a result of the thresholding procedure.
  • the following experiment shows a real-time, highly accurate bladder event detection system that does not require a reference sensor.
  • the basic algorithm structure includes three stages: initial filtering, wavelet transform, and adaptive thresholding ( FIG. 6 ).
  • the signal is initially filtered using an exponential moving average (EMA), with a low pass cutoff frequency of 0.01 Hz.
  • EMA filtering is chosen because it allows the system to operate in an almost predictive manner by assuming that repeated spikes in pressure can potentially result in a true bladder contraction.
  • the computation is inexpensive, requiring very few operations and a single unit of delay, enabling real-time operation.
  • by filtering close to DC changes in pressure are effectively limited to those caused by passive stretching of the bladder. Contractions, which occur at higher frequencies, are sustained, and while slightly attenuated, remain present in the output.
  • the output of the EMA is then processed by applying a multilevel discrete wavelet transform.
  • the Daubechies 4 wavelet was chosen as the basis function for use in the algorithm. This wavelet was chosen for its performance at extracting frequencies of interest for this application and its ease of implementation. Furthermore, the wavelets are constructed to minimize the number of filter coefficients required to approximate a given signal, reducing the computational burden on hardware implementation.
  • an adaptive threshold which considers local trends in the data, may be more robust in a real-world, ambulatory setting. Two statistical methods of adaptive thresholding were investigated, which consider either the mean and standard deviation or the quantiles within a given window size.
  • the algorithm labels a contraction when the approximation of the vesical pressure rises two standard deviations above the window mean.
  • artifacts are considered to occur when the detail coefficients, or outputs from the high pass filters, rise by the same amount. At this stage the original signal is heavily processed. Therefore, any residual artifacts will cause spikes in the detail coefficients, enabling detection. Since the bladder pressure approximation does not change significantly between subsequent windows, the mean need not be recomputed for each sample, providing a trade off between power savings and accuracy in hardware implementation.
  • the values in the window are sorted by rank order. Samples in either the approximation or detail coefficients exceeding a threshold percentile are considered bladder events or artifacts, where the threshold percentile may be adjusted by the physician. Since the list remains partially sorted, new samples can be rapidly inserted into the list. Furthermore, separate significance threshold values for approximation and detail coefficients allow algorithm tuning based on the desired detection and false positive rates.
  • the ability to optimize algorithm performance for a specific user is crucial to the successful implementation of the framework.
  • the tunable parameters included (1) sample buffer length, (2) approximation coefficient sensitivity, and (3) detail coefficient sensitivity.
  • the sample buffer length refers to the time in seconds of history to retain, while the approximation and detail coefficient sensitivity refer to the percentile required for a new input value to be classified as the start of a contraction or artifact, for approximation and detail coefficients, respectively.
  • a high value for the sample buffer length could result in a prohibitively large history buffer.
  • the data rate is halved, so it is possible to store a longer history with fewer samples while retaining the general trend of the signal. Furthermore, in a hardware implementation, this reduces the area overhead, delay, and power consumption for computing the local threshold.
  • the second and third parameters affect the probability that the algorithm will attribute pressure increases to actual bladder contractions or artifacts, and they can be individually adjusted to achieve the desired performance.
  • CS Score Conditional Stimulation Score
  • False positives ( y ) and duty cycle deviation ( z ) are linear terms weighted such that every 5 false positives and every ⁇ 50% deviation from the ideal duty cycle result in an equivalent decrease in CS Score. Additionally, combining these terms allows the system to compensate for either (1) a high number of short duration false positives (i.e. high y , low z), or (2) a small number of high duration false positives (i.e. low y , high z ), which result in scoring penalties regardless.
  • Example CS Scores for various parameter combinations are shown in FIG. 7 .
  • Algorithms may have the potential for a significant number of false positives, especially with noisy or real-world data, and so values ranging from 0 to 20 have been chosen to demonstrate the effect that a high number of false positives will have on the algorithm score.
  • Urodynamic examinations providing vesical and abdominal pressure data were collected from a total of 64 tracings from 14 human subjects sampled at 100 Hz. Note that these data were not collected for the purpose of developing this algorithm, and the sampling rate was chosen or set by the clinical equipment for the particular needs. Subjects had neurogenic detrusor overactivity and 2-9 cystometric fills were completed. These clinical tests were conducted at the Louis Stokes Cleveland Department of Veterans Affairs in Cleveland, OH (IRB #12023-H12). All procedures followed protocols that were reviewed and approved by the Institutional Review Board and followed standard clinical practices.
  • Pressures were recorded as part of clinically standard urodynamics test, which involves filling the bladder with saline to observe its behavior. Briefly, a dual lumen intraurethral catheter was inserted, with one lumen used to infuse saline into the bladder at approximately 50 ml/min, depending on the clinical scenario, and the other lumen used to measure continuous vesical pressure via an external fluidic transducer. In addition, an anorectal balloon catheter was inserted to similarly measure continuous abdominal pressure; continuous detrusor pressure was calculated as the difference between the vesical and rectal pressures. Filling was continued until a reflex bladder contraction was evoked, which usually resulted in voiding around the urethral catheter. After each cystometric fill the bladder was completely emptied.
  • GDT Global Detrusor Thresholding
  • GVT Global Vesical Thresholding
  • DWT Discrete Wavelet Transform
  • parameter optimization must seek to (1) maximize detection accuracy, (2) minimize false positives, (3) minimize detection latency between contraction onset and event detection, and (4) minimize the stimulator duty cycle. Failure to select appropriate parameters can result in oversensitivity to noise or other low amplitude pressure fluctuations. With optimally chosen parameters, a reliable and robust algorithm will have consistently high detection rates while similarly limiting the number of false positives.
  • Resulting CS Scores were analyzed using Tukey's pairwise comparison (p ⁇ 0.05) to determine if CAT is more effective than the other methods for detecting bladder contractions. Data from tuned methods and untuned methods were pooled to determine if tuning can improve efficacy. Finally, data from static methods (GDT, GVT) and adaptive methods (AVT, CAT) were pooled and tested to determine if adaptive methods are more effective than the static methods.
  • Bladder pressure is a smooth signal relative to pressures caused by abdominal pressures, and slopes in an appropriately sized window can be approximated well with linear functions.
  • FIG. 9 shows sample outputs from the CAT algorithm, specifically contraction detection ( FIG. 9(a) ) well before the contraction onset or leak point pressure (dashed line) and artifact detection ( FIG. 9(b) ), which were not classified as contractions due to the higher rate of pressure increase.
  • FIG. 9(c) gives an example of the denoising capabilities of wavelets, which demonstrates how adaptive thresholding in the wavelet domain can improve the specificity of the detection algorithm.
  • HDT did not perform significantly better than either of the static methods, despite having a moving threshold.
  • AVT and CAT both demonstrated significant improvements in detection accuracy (95% and 97%, respectively) over static methods, though the false positive rates increased slightly when compared with GDT and GVT. For most tracings, operating in the wavelet domain resulted in fewer false positives while maintaining a high degree of accuracy.
  • the CS Score accounts only for whether or not detection occurred within 1 second of contraction; the precise latency is not used for scoring. Therefore, it is important to note the differences in detection latency between the algorithms, as shown in FIG. 11 for a subset of detections. Note that negative latencies represent detection prior to contraction onset. CAT is more likely to detect contraction onset a short time in advance, reducing the possibility of overstimulation.

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Claims (8)

  1. System (10), das Folgendes umfasst:
    eine Sensoreinrichtung (12), die angepasst ist, um innerhalb der Blase eines Patienten angeordnet zu werden, wobei sie Folgendes umfasst:
    einen Drucksensor (16), der eine brückenartige Schaltung umfasst, die angepasst ist, um einen Druck innerhalb der Blase des Patienten direkt zu erfassen,
    einen drahtlosen Sender-Empfänger (18), der angepasst ist, um ein Signal zu übermitteln, das den Druck innerhalb der Blase des Patienten angibt, und
    eine Batterie (20), die angepasst ist, um Energie für den Drucksensor (16) bereitzustellen, und
    eine Signalverarbeitungseinrichtung (14), die Folgendes umfasst:
    einen drahtlosen Sender-Empfänger (22), der angepasst ist, um das Signal zu empfangen, das den erfassten Druck innerhalb der Blase des Patienten angibt, und
    einen Prozessor (24), um Anweisungen auszuführen, die in einem Speicher gespeichert sind, um das Signal zu verarbeiten und mindestens:
    das Signal, das den erfassten Druck angibt, mit einem Tiefpassfilter mit einer Grenzfrequenz, die für die Blase des Patienten abgestimmt ist, zu filtern, um ein gefiltertes Signal bereitzustellen,
    eine mehrstufige diskrete Wavelet-Transformation auf das gefilterte Signal anzuwenden, um ein transformiertes Signal in einer Wavelet-Domäne bereitzustellen,
    ein adaptives Schwellenwertverfahren auf das transformierte Signal in der Wavelet-Domäne anzuwenden, um ein Blasenereignis des Patienten zu erfassen, und
    das Blasenereignis auf Grundlage mindestens eines abstimmbaren Parameters als ein Entleerungskontraktionsereignis für die Blase des Patienten, ein Nicht-Entleerungskontraktionsereignis für die Blase des Patienten oder ein Nicht-Kontraktionsereignis für die Blase des Patienten zu charakterisieren, wobei der mindestens eine abstimmbare Parameter Folgendes ist: eine Muster-Pufferlänge für die Blase des Patienten, eine Näherungskoeffizienten-Empfindlichkeit für die Blase des Patienten und/oder eine Detailkoeffizienten-Empfindlichkeit für die Blase des Patienten.
  2. System (10) nach Anspruch 1, wobei die Signalverarbeitungseinrichtung (14) einer Neuromodulationseinrichtung (36) signalisiert, eine Stimulation zu liefern, um ein Entleeren zu verhindern, wenn das Blasenereignis als das Entleerungskontraktionsereignis für die Blase des Patienten charakterisiert wird.
  3. System (10) nach Anspruch 2, wobei ein oder mehrere Parameter der Stimulation auf Grundlage des erfassten Drucks konfiguriert sind.
  4. System (10) nach Anspruch 1, wobei die Signalverarbeitungseinrichtung (14) einer Neuromodulationseinrichtung (36) signalisiert, eine Stimulation zu liefern, um ein Auslaufen zu verhindern, wenn das Blasenereignis als das Nicht-Entleerungskontraktionsereignis für die Blase des Patienten charakterisiert wird.
  5. System (10) nach Anspruch 1, wobei die Sensoreinrichtung (12) angepasst ist, um innerhalb einer Wand der Blase angeordnet zu werden.
  6. Verfahren, das Folgendes umfasst:
    Empfangen, durch eine Signalverarbeitungseinrichtung (14), die einen Prozessor (24) umfasst, eines Signals, das einen Druck angibt, der innerhalb der Blase eines Patienten erfasst wird, von einer Sensoreinrichtung (12), wobei die Sensoreinrichtung (12) innerhalb der Blase des Patienten angeordnet ist und Folgendes umfasst:
    einen Drucksensor (16), der eine brückenartige Schaltung umfasst, die angepasst ist, um den Druck innerhalb der Blase des Patienten direkt zu erfassen,
    einen drahtlosen Sender-Empfänger (18), der angepasst ist, um das Signal zu übermitteln, das den Druck innerhalb der Blase des Patienten angibt, und
    eine Batterie (20), die angepasst ist, um Energie für den Drucksensor (16) bereitzustellen, und
    Verarbeiten, durch die Signalverarbeitungseinrichtung (14), des Signals, das den Druck angibt, was Folgendes umfasst:
    Anwenden, durch die Signalverarbeitungseinrichtung (14), eines Tiefpassfilters auf das Signal mit einer Grenzfrequenz, um Rauschen aus dem Signal zu entfernen, wobei die Grenzfrequenz abstimmbar ist,
    Anwenden, durch die Signalverarbeitungseinrichtung (14), einer mehrstufigen diskreten Wavelet-Transformation auf das gefilterte Signal, um ein transformiertes Signal in einer Wavelet-Domäne bereitzustellen, und
    Anwenden, durch die Signalverarbeitungseinrichtung (14), eines adaptiven Schwellenwertverfahrens auf das transformierte Signal in der Wavelet-Domäne, um ein Blasenereignis des Patienten zu erfassen, und
    Charakterisieren, durch die Signalverarbeitungseinrichtung, des Blasenereignisses auf Grundlage mindestens eines abstimmbaren Parameters als ein Entleerungskontraktionsereignis für die Blase des Patienten, ein Nicht-Entleerungskontraktionsereignis für die Blase des Patienten oder ein Nicht-Kontraktionsereignis für die Blase des Patienten, wobei der mindestens eine abstimmbare Parameter Folgendes ist: eine Muster-Pufferlänge für die Blase des Patienten, eine Näherungskoeffizienten-Empfindlichkeit für die Blase des Patienten und/oder eine Detailkoeffizienten-Empfindlichkeit für die Blase des Patienten.
  7. Verfahren nach Anspruch 6, wobei die Signalverarbeitungseinrichtung (14) das Blasenereignis, das als ein Nicht-Kontraktionsereignis oder ein Nicht-Enleerungskontraktion für die Blase des Patienten charakterisiert wird, von weiterer Verarbeitung ausschließt.
  8. Verfahren nach Anspruch 6, wobei die Sensoreinrichtung (12) ferner eine Driftentfernungskomponente umfasst, um Drift aus dem Druck zu entfernen, der durch den Drucksensor (16) erfasst wird.
EP16724991.1A 2015-04-29 2016-04-29 Blasenereigniserkennung zur diagnose von harninkontinenz oder behandlung von erkrankungen der unteren harnwege Active EP3288460B1 (de)

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